NCT01494090

Statin in Hip Fracture

Efficacy and Safety of Rosuvastatin in the Prevention of Arterial and Venous Vascular Events and Mortality After Hip Fracture: A Multicenter Randomised, Double-blinded, Placebo Controlled Trial.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Statins (or HMG-CoA reductase inhibitors) have largely proven their efficacy in the primary and secondary prevention of cardiovascular events. Many clinical and experimental studies support also a potential beneficial effect of statin therapy on venous thromboembolism (VTE). Patients with hip fracture are at high risk of VTE and cardiovascular events. The aim of this study is to evaluate the efficacy and the tolerance of a statin (rosuvastatin) in hip fracture surgery on the occurrence of venous and atherothrombotic events and the global mortality at six months. Subjects aged 60 years or over who are scheduled to undergo surgery for fracture of the upper portion of the femur (hip fracture) are eligible to participate to this multicentre, randomized, double-blind placebo controlled trial. They will receive either rosuvastatin (5 or 20 mg) or placebo for 6 months. The primary efficacy outcome is the incidence of an adjudicated composite of non fatal VTE, acute coronary syndrome, non fatal stroke, other acute ischemic arterial event, or all-cause death. Assuming a endpoint frequency of 20% in the control group, we calculated that 1200 patients will be required for the study to have 80% power to detect a 30% reduction in the relative risk with rosuvastatin (with a two-sided alpha level of 5%). The investigators assumed that rosuvastatin could have a positive benefit-risk ratio in patients undergoing orthopaedic surgery for hip fracture, by reducing vascular events and global mortality at six months.

Conditions

• Hip Fracture

Interventions

Type	Name	Description
DRUG	Rosuvastatin	5 or 20 mg per day during 6 months
DRUG	Placebo	5 or 20 mg per day during 6 months

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-03-01
• Completion: 2012-09-01
• First posted: 2011-12-16
• Last updated: 2012-09-20

Locations

6 sites across 1 country: France